Recall Z-1256-2011 ยท BYG Mask, Oxygen
Convatec Inc.
Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. RESPIREX Nebulizer Kits w/Aerosol Mask Adult 7 ft. (2.1m) Aerosol Tubing Manufactured for PSS World Medical Inc. Unomedical, Inc., Hospilak REF 100-E Aerosol Mask Adult
| Date | Feb 15, 2011 (initiated Jan 7, 2011) |
| Status | Terminated |
| Reason | Face tents and Oxygen masks may have a sticky glue-like substance on the inside or outside of the mask consisting of dioctyl phthalate, epoxidized soybean oil and glycerol monoleate. |
| Root cause | Nonconforming Material/Component |
| Action | Unomedical, Inc issued recall letters with attached return response forms dated January 7, 2011 via UPS. The letters request the customer stop use and quarantine product. The recall response form is to be completed and returned to Unomedical. The letters/return response form were also sent out in Spanish. Another recall letter was sent dated February 16, 2011 to capture additional lots that werent included in the initial letter. |
| Quantity | 1113200 pcs. |
| Distribution | Worldwide distribution, including USA, Puerto Rico, Canada, Mexico, Colombia, El Salvador, Paraguay, UK, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden and Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.